Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) combination has demonstrated ‘durable improvement in survival’, according to new long-term data from a Phase III trial. According to 6.5 year data from CheckMate-067, median overall survival (OS) for patients with advanced melanoma was 72.1 months with Opdivo plus Yervoy, compared with 36.9 months for patients received Opdivo alone and 19.9 months for Yervoy monotherapy. In a statement, BMS said this represented the longest reported median OS in a Phase III advanced melanoma trial. Opdivo plus Yervoy also demonstrated a 6.5-year progression-free survival (PFS) rate of 34%, versus 29% and 7% for Opdivo alone and Yervoy alone, respectively. In addition, of the 49% of patients who were alive and in follow-up, 77% who received Opdivo plus Yervoy, 69% of Opdivo-treated and 43% of Yervoy-treated patients have been off treatment and never received subsequent systemic therapy. Also, among melanoma patients with BRAF-mutant tumours, ...
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex’ applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor). The drugmaker is seeking approval for the drug’s use in combination with ivacaftor in patients ages six years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved, this will extend the indication for the triple combination therapy to children ages six through 11 years old in EU countries, Great Britain and Northern Ireland. In children with CF, symptoms and organ damage including lung disease manifest very early in life. “We are committed to working diligently with global regulators to expand the indication for our medicine such that younger people living with CF will also be able to access the triple combination therapy,” said Nia Tatsis, executive VP, chief regulatory ...
Janssen, the pharma division of Johnson & Johnson, has entered an agreement with Cambridge, UK-based Mestag Therapeutics to research and develop novel fibroblast targets for the treatment of inflammatory disease. The collaboration will utilise Mestag’s specialist fibroblast subpopulation biology platform, as well as the biotech’s ‘state-of-the-art’ data analytics in a bid to identify novel therapeutic targets. Under the terms of the agreement, Mestag will grant Janssen an option to an exclusive license to develop and commercialise therapeutics directed against up to two targets resulting from the collaboration. In exchange, Janssen will pay Mestag option fees, milestone payments and royalties – however, the detailed financial terms of the agreement were not disclosed by the companies. Also, as part of the collaboration, Janssen Research & Development’s global immunology therapeutic head David Lee will join Mestag’s scientific advisory committee. “Mestag’s vision is to leverage our unique fibroblast biology platform and state-of-the-art data analytics ...
New results from a Phase IIIa study have demonstrated that Novo Nordisk’s weight loss drug semaglutide improved physical function and wellbeing among people with obesity. The STEP 1 trial demonstrated benefits for people with obesity treated with semaglutide 2.4mg ‘beyond weight loss’, Novo said in a statement. Over a 68-week period, treatment with once-weekly semaglutide 2.4mg was associated with greater improvements for all weight- and health-related quality of life scores in people with obesity or overweight in comparison to placebo. This included improved wellbeing, with 43.8% of patients treated with Novo’s drug achieving a clinically meaningful improvement in total weight-related quality of life score at week 68. On top of that, 51.2% of participants treated with semaglutide 2.4mg in the trial had an increased weight-related physical function score, reflecting improvements in the ability to perform daily activities. In addition, patients treated with semaglutide 2.4mg ‘simultaneously’ experienced significant weight loss of ...
The European Commission approved expanded use of GlaxoSmithKline’s intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for adults with active lupus nephritis (LN). The drug is already on the market to treat systemic lupus erythematosus (SLE); this latest approval now provides physicians and patients in Europe with the first and only biologic treatment specifically designed to work in lupus and LN. “Active lupus nephritis, which causes inflammation in the kidneys, is one of the most serious consequences of systemic lupus erythematosus and occurs in more than 1 million patients worldwide,” noted Dr Hal Barron, GSK’s chief scientific officer and president R&D. “Benlysta is the first biologic approved to treat lupus and lupus nephritis, representing a significant new treatment option for patients and physicians across Europe dealing with this complex autoimmune disease.” The drug’s marketing submission was based on data from the BLISS-LN (Efficacy and Safety of Belimumab ...
Cambridge-based biotech company Alchemab has announced a new collaboration with British pharma AstraZeneca (AZ), aiming to accelerate research for prostate cancer. As part of the collaboration, Alchemab and AZ will collaborate on a proof-of-concept study to improve understanding of the ‘fundamental biology’ of prostate cancer. Alchemab will utilise its novel drug discovery platform as a diagnostic tool through the identification of disease biomarkers, with the potential to inform the development of new antibody-based medications. Under the agreement, Alchemab will sequence and explore antibody repertoires in patient samples gathered from a clinical trial of an undisclosed immuno-oncology agent within AZ’s pipeline. Alchemab may also be able to identify antibody sequence patterns that could be used as biomarkers for early detection and patient stratification by classifying patients into two groups – responders and non-responders. The overall purpose of the collaboration is to identify novel and disease-relevant antibodies which may generate therapeutic insights into ...
The Royal Pharmaceutical Society of Great Britain (RPS) has made new recommendations to increase the use of pharmacist independent prescribers (PIP) in the UK. In a statement, RPS highlighted that the role of PIPs has become ‘increasingly’ important in delivering high-quality clinical care. The Society added that it wants to see increased use of PIPs in multi-disciplinary teams to expand patient access to care, as well as create capacity in the healthcare system and improve health outcomes. The three core recommendations call on governments and healthcare organisations to proactively: establish the right infrastructure, systems and tools to enable patients to benefit from PIPs develop the PIP workforce required to work routinely as part of multi-professional teams in all health care settings provide ongoing professional development for PIPs as well as expand their role in teaching and peer support. “Non-medical prescribing was introduced in the UK some 30 years ago, but ...
Sanofi and AstraZeneca’s (AZ) monoclonal antibody (mAb) nirsevimab reached its primary endpoint in a Phase III trial, demonstrating protection against respiratory syncytial virus disease (RSV) in healthy infants. Nirsevimab, an investigational extended half-life mAb is designed to protect infants entering their first RSV season, when they are at a higher risk for developing severe RSV disease. In the Phase III MELODY trial, nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention due to RSV in healthy preterm and term infants. There were no clinically meaningful differences observed in the safety results between the nirsevimab and placebo groups, with the overall safety profile for nirsevimab in the trial remaining consistent with previously reported results. “Respiratory syncytial virus is the leading cause of hospitalisations in all infants,” said Jean-François Toussaint, global head of research and development, Sanofi Pasteur. “In fact, most hospitalisations occur in otherwise healthy infants born at term. It’s ...
A new report suggests that the gender pay gap for doctors has increased during the pandemic, with female doctors found to be disproportionately affected by falling earnings. The Medscape UK Doctors’ Salary and Sanctification Survey 2021, conducted between 10 November 2020 to 16 February 2021, includes responses from over 1,000 doctors in England, Scotland, Wales and Norther Ireland. This includes doctors from a range of specialities, with 73% working in the NHS, 23% working in both the NHS and private sector and 4% in the private sector only. The report considers changes in doctors’ average salaries since Medscape’s last salary and satisfaction survey released in 2019. It found that overall, 29% of UK doctors reported a drop in income, compared with 17% in 2019. Some doctors attributed the decrease in earnings to COVID-19 ‘multiple times’, while others cited different reasons. The report also suggests that women have suffered a greater ...
GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe. Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older. TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs. The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely. The EC approval is based on data from a Phase III trial evaluating Epidyolex for the treatment of seizures associated with TSC. This study hit its primary endpoint of reduction in seizure frequency, with seizure reduction ...
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